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Clinical Trial - Vaccine Therapy in Treating Patients with DCIS of the Breast
Vaccine Therapy in Treating Patients with Ductal Carcinoma in Situ of the Breast
This study is currently recruiting participants. Verified by National Cancer Institute (NCI), June 2009 First Received: June 17, 2009 Last Updated: July 9, 2009 History of Changes Sponsor:University of PennsylvaniaCollaborator:National Cancer Institute (NCI) Information provided by:National Cancer Institute (NCI)ClinicalTrials.gov Identifier:NCT00923143 Purpose RATIONALE: Vaccines made from a person's white blood cells mixed with peptides may help the body build an effective immune response to kill tumor cells. PURPOSE: This randomized phase I/II trial is studying the side effects and best way to give vaccine therapy and to see how well it works in treating patients with ductal carcinoma in situ of the breast. ConditionInterventionPhaseBreast Cancer Biological: HER-2/neu peptide vaccine Biological: therapeutic autologous dendritic cells Phase I Phase II Study Type:InterventionalStudy Design:Allocation: Randomized Primary Purpose: TreatmentOfficial Title:A Randomized Trial of HER-2/Neu Pulsed DC1 Vaccine for Patients With DCIS Resource links provided by NLM: Genetics Home Reference related topics: breast cancer MedlinePlus related topics: Breast Cancer Cancer U.S. FDA Resources Further study details as provided by National Cancer Institute (NCI): Primary Outcome Measures:
Secondary Outcome Measures:
Estimated Enrollment:57Study Start Date:March 2009Estimated Primary Completion Date:June 2013 (Final data collection date for primary outcome measure) ArmsAssigned InterventionsArm I: Experimental Patients receive HER2/neu peptide-pulsed autologous type 1 dendritic cell vaccine intranodally into 1-2 different normal groin or axillary lymph nodes once weekly for 6 weeks. Interventions:
Biological: therapeutic autologous dendritic cells Given intranodally and/or intralesionally Arm II: Experimental Patients receive HER2/neu peptide-pulsed autologous type 1 dendritic cell vaccine intralesionally into the quadrant of the affected breast once weekly for 6 weeks. Interventions:
Biological: therapeutic autologous dendritic cells Given intranodally and/or intralesionally Arm III: Experimental Patients receive HER2/neu peptide-pulsed autologous type 1 dendritic cell vaccine intranodally and intralesionally as in arms I and II. Interventions:
Biological: therapeutic autologous dendritic cells Given intranodally and/or intralesionally Detailed Description: OBJECTIVES: Primary
Patients undergo leukapheresis to obtain monocyte fractions for generation of the vaccine. The monocytes are cultured with GM-CSF, interleukin-4, interferon gamma, and lipopolysaccharide and pulsed with HER2/neu peptides for the production of type 1 dendritic cells.
After completion of study treatment, patients are followed up every 6 months for 5 years and then annually thereafter. Eligibility Ages Eligible for Study: 18 Years and olderGenders Eligible for Study: BothAccepts Healthy Volunteers: NoCriteria DISEASE CHARACTERISTICS:
Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT00923143 Locations United States, PennsylvaniaAbramson Cancer Center of the University of PennsylvaniaRecruitingPhiladelphia, Pennsylvania, United States, 19104-4283Contact: Clinical Trials Office - Abramson Cancer Center of the Univers 800-474-9892 Sponsors and Collaborators University of Pennsylvania National Cancer Institute (NCI) Investigators Principal Investigator:Brian J. Czerniecki, MD, PhDAbramson Cancer Center of the University of Pennsylvania More Information Additional Information: Clinical trial summary from the National Cancer Institute's PDQ® database No publications provided Responsible Party:Abramson Cancer Center of the University of Pennsylvania ( Brian J. Czerniecki )ClinicalTrials.gov Identifier:NCT00923143 History of ChangesOther Study ID Numbers:CDR0000644921, UPCC-15107, 807010Study First Received:June 17, 2009Last Updated:July 9, 2009Health Authority:Unspecified Keywords provided by National Cancer Institute (NCI): ductal breast carcinoma in situ HER2-positive breast cancer male breast cancer Additional relevant MeSH terms: Breast Neoplasms Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Adenocarcinoma Neoplasms, Ductal, Lobular, and Medullary ClinicalTrials.gov processed this record on January 31, 2011 Back to top of Main Content accine Therapy in Treating Patients with Ductal Carcinoma in Situ of the Breast |
Re: Clinical Trial - Vaccine Therapy in Treating Patients with DCIS of the Breast
Becky,
Thanks for keeping us informed on the latest trials. This one is really exciting. I do hope some of our gals who qualify will get involved. Go PA ( I grew up there). Donna |
Re: Clinical Trial - Vaccine Therapy in Treating Patients with DCIS of the Breast
I participated in this trial. Had no side effects and it ate all my DCIS/Her2/neu. Dr. Czerniecki wants to include invasive Her2/neu, triple negative and ER recpetor + in the next trial. Will keep everyone posted. Has had great results, trial designed to increase immunity, but they are finding the diseased areas are disappearing and less surgery is needed. In my case, it was all gone. In larger areas of DCIS, in one case it shrunk 98% in six weeks and he speculates if the vaccine were given longer, we might see the entire area clear.
Thanks, Shelley Dodt www.shelleydodt.com if anyone wants more info |
Re: Clinical Trial - Vaccine Therapy in Treating Patients with DCIS of the Breast
Just wanted to update everyone on Dr. Czerniecki's DCIS/Her2/neu vaccine trial at P\University of Pennsylvania. I ask him and he told me he is seeing immune response in 90% of trial patients, 40% of them have complete response (immune response plus tumor area gone). Also in the group given the vaccine that is Er and Pr receptor negative and Her2/neu positive (G=20) there have been NO recurrences! So please let everyone find out about this trial who might be eligible (DCIS and Positive for Her2/neu regardless of ER and Pr receptor status) I was one of the lucky ones who GOT the vaccine. Website www.shelleydodt.com.
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Re: Clinical Trial - Vaccine Therapy in Treating Patients with DCIS of the Breast
Hi Shelley,
Nice to have met you in California this summer. Thanks for the update! Joan |
Re: Clinical Trial - Vaccine Therapy in Treating Patients with DCIS of the Breast
Does anyone know if this vaccine will be used as a preventative measure? I was diagnosed with DCIS in one breast in 2005. With my family history of BC, I chose bilateral mastectomy. I've been cancer free for 6 years!!! Praise God! However, I do have a daughter that is only 20 years old and am thinking about her chances of getting this diagnosis some day. I pray this doesn't happen. I was 43 years old when diagnosed.
I was wondering if this vaccine would prevent it from occurring???? Thanks, |
Re: Clinical Trial - Vaccine Therapy in Treating Patients with DCIS of the Breast
I was actually accepted into this trial! Good stuff!
I did quite a bit of research before applying to the study and it is a fabulous study! Nice to "meet" some of the ladies who were in the research results that I have read! I have a question.....since I haven't had treatment yet and don't really understand how the entire process works, how do they know the DCIS shrunk prior to surgery? Someone mentioned that they needed less surgery, did you know that going into surgery? Or was it something that was discovered after surgery? Just very very curious |
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